Is Melatonin legal in Italy?

Formal status

There is no EU-harmonised limit for melatonin in food supplements - each member state sets its own rule.

Italy permits melatonin in food supplements up to 1 mg per day. The Ministry of Health set this ceiling by circular in June 2013, effective 1 October 2013, reducing it from 5 mg to align with the EFSA-assessed dose supporting the authorised sleep-onset claim and to demarcate supplement use from the 2 mg prolonged-release melatonin medicines authorised in the EU. Above 1 mg per day the product falls to be treated as a medicine. Melatonin appears in the Ministry's "other substances" table with that intake limit, so a compliant supplement route is fully available - entirely separate from the cannabinoid prohibitions affecting the rest of the formula.

Do we sell here?

Not at the moment.

Melatonin itself is not the reason we don't sell 01 Sleep in Italy - our 1mg dose is comfortably inside Italy's 1mg supplement ceiling, with no grey area. The product is unavailable there because of its CBD and CBN content, not its melatonin content.

Outlook

Italy's 1 mg ceiling has been stable since 2013 with no indication of movement. It exists to keep supplement use distinct from the 2 mg prolonged-release melatonin medicines authorised in the EU, so any future change would most likely follow EU-level harmonisation rather than an Italian initiative.

Timeline

June 2013

The Ministry of Health cuts the maximum melatonin content of food supplements from 5 mg to 1 mg per day, effective 30 September 2013, to align with the EFSA-assessed claim dose and to demarcate supplements from 2 mg melatonin medicines.

NutraIngredients

Ingredients

Browse legality of our other ingredients in Italy.